Job Description

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The Project Data Manager (PDM) leads and oversees data management activities, timelines and finances of the Allucent Data Management (DM) department.
This position manages and coordinates DM deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting.
This position acts as a Project Manager and is responsible for the overall coordination and management of Data Management/Biostats standalone projects, large and complex trials and/or multiple projects belonging to one client.
This position oversees day-to-day operations and coordinates planning and operational activities of assigned junior team members, like, CDM1, CDM2 and CDM3 and their assigned projects.
The PDM is a member of the Data Management staff.
Requirements:
Lead and serve as primary contact for DM with all relevant parties both internally (e.g. Biostatistics and if applicable other functional groups, such as Project Management, Clinical Operations) and externally (e.g. sponsors, vendors (EDC, external data), investigational sites)
As a Project Manager for Biometrics stand-alone studies, the Project Data Manager will:
Lead and coordinate the Biometrics project team, ensuring the project is delivered according to planned scope and timelines in accordance with the contract
Create and execute project management plans required for project delivery and in accordance with established processes
Establish requirements for and ensure project-specific training plan for internal team members
Establish clear communication lines and escalation pathways, communicate with project stakeholders, both internally (e.g. Clinical Programmers, Data Scientists, Biostatistics and other functional groups) and externally (e.g. sponsors, vendors (EDC, external data) and other external parties)
Establish requirements for and ensures project-specific training plan for internal team members
Lead and serve as primary contact for DM with all relevant parties both internally (e.g. Biostatistics and if applicable other functional groups, such as Project Management, Clinical Operations) and externally (e.g. sponsors, vendors (EDC, external data), investigational sites)
As a Project Manager for Biometrics stand-alone studies, the Project Data Manager will:
Lead and coordinate the Biometrics project team, ensuring the project is delivered according to planned scope and timelines in accordance with the contract
Create and execute project management plans required for project delivery and in accordance with established processes
Establish requirements for and ensure project-specific training plan for internal team members
Establish clear communication lines and escalation pathways, communicate with project stakeholders, both internally (e.g. Clinical Programmers, Data Scientists, Biostatistics and other functional groups) and externally (e.g. sponsors, vendors (EDC, external data) and other external parties)
Establish requirements for and ensures project-specific training plan for internal team members
Establish project risk management plan with input from client and functional stakeholders and oversee adherence and updates throughout the project lifecycle
Lead internal meetings with internal team members and external meetings with a sponsor, and third party (data) vendors, including Kick Off Meetings (KOM) and Investigator Meetings based on project scope
Provide support for vendor identification, qualification and selection and manage vendors
Manage vendors and vendor relationships as required for project delivery
Arrange, maintain and circulate project progress and status reports
In addition, as a Project Manager for Biometrics stand-alone studies and/or large, complex or multiple studies with same client, the Project Data Manager will:
Lead the Biometrics project team, ensuring the project is delivered according to planned scope and timelines in accordance with the contract
Ensure overall consistency across all client studies within a set of projects; this especially relates to the DM activities; Data Management Plan (DMP), CRF design, data cleaning and query management) and for Biometrics stand-alone projects also include statistical deliverables (SAP, TLFs)
Lead internal meetings with internal project team members. Support and participate in external meetings with a sponsor, including Kick Off Meetings (KOM) and Investigator Meetings based on project scope
Interact, negotiate and influence internal and external team members in a professional manner and with successful outcomes
Ensure effective and efficient resource utilization across projects and programs
Manage the study budget, evaluate financial project health and manage monthly status updates for invoicing. Participate in monthly project review meetings
Proactively recognize and address any changes in scope. Liaise to execute contract amendments
Oversee Sponsor relationships
Assist in contracts negotiation and contracting process with vendors (EDC, IRT)
May support operational Data Management activities, also to ensure and assess quality
Oversee and ensure the Trial Master File for DM services in scope is kept up to date and audit/inspection ready.
Contribute to other areas of business as required
Research, propose and lead initiatives for improving efficiency
Manage direct reporting staff, perform performance reviews and support team member personal development plans
Oversee and supervise work done by junior team members (CDM1 level - CDM3 level)
Actively support to staff learning & development within the company
Share relevant information at applicable DM departmental meetings and organize and lead DM-related meetings and discussions
Represent the company through active participation at professional meetings, webinars or seminars
Provide and coordinate Data Management training for relevant staff. Support in development of new training material
Train and mentor data management staff, support in development of new training material and provide training to relevant staff
Participate in the interview process for new recruits
Proactively track Data Management related regulatory development trends and updates, in consultation with department Global Head and/or Senior Directors, for further alignment and improvement of current processes
Quality Management
Contribute as Clinical Data Management Subject Matter Expert (SME) to the evaluation/improvement/drafting of processes and procedures within the Quality Management System
Account Management, Sales & Acquisition
Assure good communication and relationships with (future) clients
Contribute to and take part in client evaluations and visits
Support in preparation of new proposals and budgets for Data Management services
Support Business Development (BD) in preparing and providing presentations to potential and existing clients through attendance at capabilities and/or bid defense meetings
Provide input into tools and templates to support costing and bidding
Others
Contribute to other areas of business as required
10% Travel
Education Requirements and Qualifications
Qualifications
Life science, healthcare degree and/or combination of education and experience
Minimum 8 years of relevant work experience in Clinical Data Management or related experience within Biometrics
Minimum 8 years of relevant experience in related clinical trials environment
Thorough knowledge and understanding of ICH-GCP, 21CFR11 data privacy (GDPR/HIPPA) guidelines and awareness of local/regional requirements
Good understanding of Medical Terminology
Experience as DM Lead on several studies and experience in covering all phases of a clinical study (start up, conduct and database lock). Worked on multiple indications and clinical phases (I-IV)
Thorough understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation
Experienced in CDISC conventions, i.e., CDASH, TAUG models and hands on experience implementing these models
Client management experience
Experience in developing data management standards
Skills
Strong written and verbal communication skills including good command of English language
Representative, outgoing and client focused
Ability to work in a fast-paced challenging environment of a growing company
Proficiency with various computer applications such as Word, Excel, and PowerPoint required
Administrative excellence
Attention to detail, strong technical, analytical and problem-solving skills
Strong project management skills
Ability to translate guidelines, rules and regulations in clear and usable recommendations
Ability to simplify complex issues into understandable concepts
Excellent organizational, negotiating and motivational skills
Benefits:
Benefits of working at Allucent include:

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Leadership and mentoring opportunities
• Participation in our enriching Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program
• Access to online soft-skills and technical training via GoodHabitz and internal platforms
• Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
• Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees

Disclaimers:
"The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources."

Skills Required